New York State Hepatitis C Virus Rapid Testing Program - Provider Enrollment

NYS Hepatitis C Rapid Testing Program Implementation Guide Home Page

Introduction

Since 2012, the New York State Department of Health (NYSDOH) hepatitis C virus (HCV) Rapid Testing Program (RTP) has offered free HCV rapid antibody test kits and controls to enrolled programs serving underinsured individuals at highest risk for contracting HCV.  The Centers for Disease Control and Prevention (CDC) estimates that approximately 2.7-3.9 million people are currently living with HCV, though most individuals are unaware of their HCV status.  This program is designed to identify and screen individuals at risk—specifically those high-risk individuals not engaged in routine health care—, to provide risk-specific HCV counseling messages, and to link HCV rapid antibody reactive individuals to diagnostic testing, care, and treatment.  Today’s HCV treatment landscape has revolutionized care for patients living with HCV.  Therapies are simpler, well-tolerated, and have a much higher cure rate.   Screening, diagnosing and linking high-risk persons to care are important steps towards decreasing HCV related morbidity and mortality.

What is HCV Rapid Testing?

Programs completing enrollment in the NYS HCV RTP are provided with the OraQuick® HCV Rapid Antibody Test.  The OraQuick® HCV Rapid Antibody Test is the only rapid testing technology currently available for HCV screening.  This test has been waived under the Clinical Laboratory Improvement Amendment (CLIA) regulations for use with fingerstick and venipuncture whole blood specimens from individuals 15 years and older.  This assay has not been FDA approved for use in populations without signs, symptoms, or those not at risk for hepatitis C infection.

The OraQuick® HCV Rapid Antibody Test is a screening test used to detect HCV antibodies (anti-HCV).  This is only a screening test.  It is not a diagnostic test and cannot determine the stage of HCV infection (i.e. current or previous HCV infection).  Testing for hepatitis C is a two-step process.  To determine if an individual is currently infected, diagnostic testing (HCV RNA) must be performed.  Programs enrolled in the NYS HCV RTP must, at minimum, refer those with HCV rapid antibody reactive tests to a health care provider for HCV RNA testing.  The NYS HCV RTP partners with the Wadsworth Center, Bloodborne Viruses Laboratory (BVL) to offer immediate access to HCV RNA testing for pre-qualified enrolled programs. For more information see Linkage to Diagnostic Testing & Care.

What are New York State Hepatitis C Virus Rapid Testing Program Requirements?

A key element of enrollment is determining all program resources for HCV testing, including third party reimbursement and/or AIDS Institute (AI) contracts that support the purchase of HCV rapid antibody test kits or HCV RNA testing.  If a program is unsure whether HCV testing is a fundable service on the agency’s AI contract, or whether the use of AI contract funds to purchase the test kits is limited to specific target populations (e.g., MSM, women, etc.), please contact the agency’s AI contract manager. 

Programs may not bill a client's health insurance, including Medicaid, for an HCV screening test conducted with a test kit received free through this program. Test kits should only be used for clients who are:

  1. uninsured or whose insurance does not reimburse for HCV screening;
  2. accessing services on a sliding fee scale; or
  3. attending events where testing services are not billed (e.g., outreach events), or in testing venues where clients' insurance statuses are not assessed.

Does your program have the capacity to participate in the New York State Hepatitis C Virus Rapid Testing Program?

Programs seeking enrollment in the NYS HCV RTP should contact the Bureau of Hepatitis Health Care at 518-486-6806 or hepatabc@health.ny.gov to discuss eligibility.  Enrollment is contingent on available funding, with priority given to programs serving those at highest risk for HCV infection.  Eligible providers will be placed on a waiting list in the event of NYS HCV RTP resource limitations. 

Eligible programs must fulfill the following requirements.  Technical assistance will be provided as needed.

  • Demonstrate the ability to reach the population - programs must engage persons at highest risk for HCV infection who have no other pay source for testing. The NYS HCV RTP follows the Testing Recommendations for Hepatitis C Virus Infection as outlined by the Center for Disease Control and Prevention (CDC).
  • Secure authorization for testing - In NYS, tests performed by Limited Service Laboratories (LSL) must be ordered by physicians or other health care providers, such as a nurse practitioners or physician assistants, who are legally authorized (by NYS professional practice law) to use the results of clinical laboratory tests in the practice of their profession. Authorization for testing must be documented in the program policy and procedure manual. Staffing at the enrolled program will determine whether standing or patient-specific orders are required.
    • Licensed Staff Conducting HCV Rapid Tests - In 2014, New York State (NYS) Education Law (Section 6527, subdivision 6 and Section 6909, subdivision 4) regarding the use of non-patient specific orders for registered professional nurses (RNs) was amended to include tests that detect the presence of HCV. This law permits licensed physicians and certified nurse practitioners to issue non-patient specific orders for RNs who may be providing HCV testing to patients.
    • Non-Licensed Staff Conducting HCV Rapid Tests - Neither standing nor patient-specific orders are required for non-licensed staff conducting the HCV rapid antibody test.  The agency-designated ordering provider is responsible for oversight of all testing performed at the program.
  • Obtain a valid Limited Service Laboratory (LSL) Registration Certificate - Programs must have a valid LSL Registration Certificate that lists HCV, Rapid on the certificate.  Depending on testing configuration, Community Screening may also need to be included as an approved procedure on the LSL Registration Certificate (testing conducted off-site on a “carry in-carry out” basis).  More information on LSL Registration Certificates is available at: https://www.wadsworth.org/regulatory/clep/limited-service-lab-certsFor more information, see Program Requirements.
  • Create Policies and Procedures - enrolled programs must have written policies and procedures specific to HCV testing and inclusive of HCV laboratory testing protocols. While these protocols do not need to be submitted to the Clinical Laboratory Evaluation Program (CLEP) prior to amending a LSL certificate, they must be reviewed and approved by the NYS HCV RTP prior to enrollment. For more information, see Program Requirements.
  • Obtain a Linkage Agreement for diagnostic testing (HCV RNA) - enrolled programs must establish and provide a copy of at least one active, written linkage agreement with a healthcare provider who can, at a minimum, perform HCV RNA testing. The health care provider must be willing to accept referrals for underinsured individuals. For more information, see Linkage to Diagnostic Testing & Care.
  • Secure access to the NYS Health Commerce System (HCS) - enrolled programs order HCV rapid antibody test kits and controls via a restricted site on the HCS.  NYS HCV RTP staff recommend that at least two program staff persons have active HCS accounts.  Assistance with determining current access to and/or securing new HCS accounts will be provided as part of the enrollment process.  For more information, see Ordering Supplies and Data Reporting.
  • Report data monthly - all enrolled programs are required to submit monthly data on testing activities. Programs may report data via the Health Commerce System (HCS) or the AIDS Institute Reporting System (AIRS). For more information, see Ordering Supplies and Data Reporting.
  • Participate in Site Visits - all enrolled programs are required to participate in periodic site visits and/or other yearly program quality assessments.  The NYS HCV RTP will monitor compliance with program requirements and provide technical assistance to ensure quality service delivery. For more information, see Quality Assurance.

How does the New York State Hepatitis C Virus Rapid Testing Program assist with enrollment?

  In addition to these general considerations, programs must also meet NYS HCV RTP enrollment requirements outlined in the following checklist and detailed in the Program Requirements Section of this manual. For more information, see Program Requirements.

NYS HCV RTP Enrollment Checklist